Caravel CRV150-19PRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04547327108782), received between Nov 1, 2017 and Feb 9, 2026 — classified as 10 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2026Material Separation

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A MILDLY CALCIFIED, MILDLY FLEXUOUS, AND MODERATELY TORTUOUS CHRONIC TOTAL OCCLUSION (CTO) IN THE RIGHT CORONARY ARTERY (RCA). AN ASAHI CARAVEL MICROCATHETER WAS USED TO ANTEGRADELY CROSS THE RCA AND THEN RETROGRADELY ADVANCED THROUGH AN EPICARDIAL COLLATERAL CHANNEL TO CROSS SEPTAL CHANNELS AND THE GRAFT. HOWEVER, CROSSING THE CTO WAS UNSUCCESSFUL. WHEN THE CARAVEL MICROCATHETER WAS BEING REMOVED EX SITU, THE DISTAL TIP OF THE CATHETER WAS FOUND IN THE PATIENT ANATOMY. THEN INTENDED TREATMENT WAS DISCONTINUED, AND A REPEAT ATTEMPT TO CROSS THE CTO LESION WAS PLANNED. THE PHYSICIAN CONCLUDED THAT THE CATHETER FRAGMENT WOULD CAUSE NO ISSUE AND COULD BE LEFT IN SITU. THE DESCRIPTION IN THE INITIAL REPORT INCORRECTLY STATED: THEN INTENDED TREATMENT WAS COMPLETED WITHOUT DELAY OR ISSUE. THE PHYSICIAN CONCLUDED THAT THE CATHETER FRAGMENT WOULD CAUSE NO ISSUE AND COULD BE LEFT IN SITU. IT WAS INFORMED THAT THERE WERE NO HEALTH HAZARDS CAUSED TO THE PATIENT DUE TO THE REPORTED EVENT. THEREFORE, THE POST-EVENT DESCRIPTION WAS CHANGED TO: THEN INTENDED TREATMENT WAS DISCONTINUED, AND A REPEAT ATTEMPT TO CROSS

  Patient problems: Foreign Body In Patient

  MAUDE report 24288754 ↗
• MalfunctionFeb 4, 2026Material Fragmentation

  WHILE ATTEMPTING TO GO RETROGRADE THROUGH AN EPICARDIAL, THE OPERATOR NOTICED A PIECE OF THE DISTAL TIP OF THE CARAVEL MICROCATHETER HAD SHEARED OFF. THE PIECE OF THE MICROCATHETER WAS NOTICED WHILE REMOVING THE CARAVEL FROM THE ANATOMY. THE OPERATOR ATTEMPTED GOING RETROGRADE THROUGH THIS EPICARDIAL AFTER ATTEMPTING TO GO ANTEGRADE THROUGH THE NATIVE RCA AND TRYING TO GO RETROGRADE THROUGH THE SEPTALS AS WELL AS THE GRAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260132 ↗
• MalfunctionDec 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A 90-99% STENOSIS IN THE OBTUSE MARGINAL BRANCH (OM). AN ASAHI CARAVEL MICROCATHETER AND A TERUMO RUNTHROUGH NS GUIDE WIRE WERE USED TO CROSS THE LESION. AFTER CROSSING THE LESION, THE COIL OF THE RUNTHROUGH NS GUIDE WIRE WAS FOUND LOOSENED AND FOREIGN OBJECT WAS OBSERVED ON THE GUIDE WIRE BY ANGIOGRAPHY. WHEN ALL DEVICES WERE WITHDRAWN, THE TIP OF THE CARAVEL MICROCATHETER WAS TORN OFF. IT WAS CONFIRMED THAT NO FRAGMENTS REMAINED IN THE PATIENT ANATOMY. THE DEVICES WERE THEN REPLACED WITH AN UNSPECIFIED GUIDING CATHETER, A CARAVAL MICROCATHETER, AN ASAHI SION BLUE GUIDE WIRE, AN UNSPECIFIED GUIDE EXTENSION CATHETER, AND AN UNSPECIFIED STENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT AND THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23724227 ↗
• MalfunctionNov 20, 2025Material Fragmentation; Unraveled Material; Material Fragmentation; Unraveled Material

  THE PATIENT WAS SET UP FOR A PCI OF THE OBTUSE MARGINAL. FEMORAL ACCESS WAS ACHIEVED AND A 6F 3.5 EBU GUIDE WAS UTILIZED. THE PHYSICIAN USED A CARAVEL AND TERUMO RUNTHROUGH WIRE. AFTER NOTICING THE GUIDE WIRE UNCOILED AFTER CROSSING, HE ALSO NOTICED SOMETHING ON THE WIRE UNDER FLUOROSCOPY. HE THEN REMOVED EVERYTHING AND NOTICED THE CARAVEL TIP CAME OFF. AFTER HE CONFIRMED NOTHING WAS LEFT IN THE PATIENT, HE PROCEEDED WITH PROCEDURE WITH SAME GUIDE CATHETER AND NOW CHANGED OUT FOR SION BLUE, CARAVEL, GUIDE EXTENSION, AND STENT. HE COMPLETED THE PROCEDURE IN THE NORMAL FASHION WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610491 ↗
• MalfunctionNov 2, 2023Material Fragmentation; Material Fragmentation

  PHYSICIAN STARTED OUT WITH A CORSAIR, AND MOVED TO CARAVEL AND TIP DISLODGED AND LEFT IN PATIENT. NO ADVERSE EVENTS, PATIENT IS DOING FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18061587 ↗
• InjuryOct 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ASAHI CARAVEL MICROCATHETER WAS USED TO CROSS A MODERATELY CALCIFIED LESION AT THE MID LEFT CIRCUMFLEX CORONARY ARTERY (LCX) DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI). WHEN THE CARAVEL MICROCATHETER GOT CAUGHT IN THE LESION AND WITHDRAWAL MANIPULATION WAS APPLIED, THE CATHETER TIP WAS DETACHED AND LEFT IN THE PATIENT ANATOMY. ALTHOUGH AN ATTEMPT WITH SNARE WAS MADE TO RETRIEVE, THE TIP FRAGMENT WAS EMBEDDED IN THE CALCIUM AND COULD NOT BE REMOVED. THE PHYSICIAN DECIDED TO TREAT THE PATIENT CONSERVATIVELY AND STOPPED THE PROCEDURE. IT WAS INFORMED THAT THERE WAS NO IMPACT ON THE PATIENT, WHO WAS DISCHARGED AFTER THE PROCEDURE AND WAS DOING FINE WITH NO HEALTH HAZARD.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18036953 ↗
• InjuryDec 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI CARAVEL MICROCATHETER SEPARATED DURING A RETROGRADE PCI APPROACHING THROUGH RCA EPICARDIAL TO LAD. AN ASAHI CORSAIR PRO XS MICROCATHETER WAS ADVANCED WITH NO ISSUES OVER AN ASAHI SION BLACK GUIDE WIRE. XS WOULDN'T PASS CORKSCREW SPIRAL IN EPICARDIAL COLLATERAL. SION BLACK WAS CHANGED OUT FOR SUOH 03 GUIDE WIRE. WIRE WAS ABLE TO TRAVEL INTO LAD AND TO DISTAL CAP OF THE PROX LAD CTO. XS WAS UNABLE TO CONTINUE ALONG SUOH 03. XS WAS EXCHANGED FOR CARAVEL. CARAVEL WAS UNABLE TO NAVIGATE THROUGH THE CORKSCREW SPIRAL. CARVEL WAS REMOVED AND IT APPEARED TO FRACTURE IN EPICARDIAL. ON FLUOROSCOPY, IT APPEARED AS A RADIOPAQUE WELD POINT ON THE SUOH 03. MAKING ASSUMPTIONS THAT THE SUOH 03 MAY HAVE KINKED OR SPLINTERED. FINECROSS M3 WAS THEN ADVANCED OVER SUOH 03. M3 WOULDN'T PASS CORKSCREW AS WELL, M3 AND SUOH 03 WERE REMOVED. THERE WAS A SLICE OF SOMETHING LEFT IN THE EPICARDIAL. A NEW SUOH 03 WAS INSERTED OVER THE M3 AND BOTH WIRE AND MICROCATHETER WERE ADVANCED TO DISTAL SEGMENT OF THE CTO, USING SAME EPICARDIAL. RETAINED ITEM WASN'T RETRIEVED FROM EPICARDIAL. NO ADVERSE OUTCOMES OCCURRED. PATIENT REMAINED STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16048857 ↗
• MalfunctionAug 24, 2020Break; Device Slipped; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Difficult to Advance

  THE TIP OF THE CARAVEL CATHETER BROKE OFF. THE CATHETER HAD BEEN ADVANCED PAST THE LESION AFTER A BALLOON AND CORSAIR HAD FAILED. THE CATHETER WAS REMOVED BALLOONING WAS PERFORMED. THE SECOND PASS WITH THE CARAVEL DID NOT ADVANCE AS SMOOTHLY WHEN DR. HALIM WENT TO REMOVE THE CATHETER THE MAIN BODY OF THE CATHETER CAME OUT BUT THE TIP WAS STILL IN THE ARTERY OVER THE WIRE. THE WIRE WAS PULLED BACK AND THE CATHETER REMAINED ATTACHED TO THE WIRE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND THERE WERE NO ADVERSE REACTIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10446455 ↗
• InjuryAug 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI CARAVEL MICROCATHETER BROKE OFF DURING A PCI TO TREAT A SEVERELY CALCIFIED 90-99% STENOSIS IN THE LAD. THE CARAVEL CATHETER HAD BEEN ADVANCED PAST THE LESION AFTER A BALLOON AND CORSAIR MICROCATHETER HAD FAILED. THE CATHETER WAS REMOVED AND BALLOONING WAS PERFORMED. THE SECOND PASS WITH THE CARAVEL WAS ATTEMPTED. IT DID NOT ADVANCE AS SMOOTHLY. WHEN THE PHYSICIAN WENT TO REMOVE THE CATHETER, THE MAIN BODY OF THE CATHETER CAME OUT BUT THE TIP WAS STILL IN THE ARTERY OVER THE WIRE. THE WIRE WAS PULLED BACK WITH THE SEPARATED TIP ATTACHED TO THE WIRE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND THERE WERE NO ADVERSE REACTIONS OR COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10441033 ↗
• InjuryFeb 26, 2020Break

  THE CATHETER TIP SHEARED OFF GOING THROUGH THE LESION. SOME RESISTANCE WHEN PULLING OUT. TIP BROKE OFF IN PLAQUE. SNARED TIP OUT AT END OF CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9758978 ↗
• InjuryJan 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UF REPORT #: (B)(4) WAS RECEIVED. IT WAS REPORTED THAT THE TIP OF CARAVEL MICROCATHETER BROKE OFF INTO THE PATIENT'S RCA AND EVENTUALLY DRIFTED INTO A SIDE BRANCH LEADING TO MINIMAL CONCERN.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 9630463 ↗
• MalfunctionJan 10, 2020Break; Detachment of Device or Device Component

  TIP OF CARAVEL BROKE OFF INTO THE PATIENTS RCA AND EVENTUALLY DRIFTED INTO A SIDE BRANCH LEADING TO MINIMAL CONCERN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9575917 ↗
• InjuryDec 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ASAHI CARAVEL MICROCATHETER WAS USED IN A PLAIN OLD BALLOON ANGIOPLASTY TO TREAT AN UNSPECIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA) WHEN THE MICROCATHETER BROKE OFF INSIDE THE RCA AND EMBOLIZED DOWN THE ARTERY. THE SEPARATED PIECE OF THE MICROCATHETER WOULD NOT BE RETRIEVED AND WAS LEFT IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; Vessel Or Plaque, Device Embedded In

  MAUDE report 9455531 ↗
• InjuryNov 21, 2019Break; Entrapment of Device

  MICROCATHETER BROKE OFF INSIDE A PATIENT'S RCA AND EMBOLIZED DOWN THE ARTERY PIECE OF CATHETER LEFT IN PATIENT DUE TO R/B OF RETRIEVAL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9356091 ↗
• InjuryDec 24, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ON "DECEOMBER" 18, 2018, THE MANUFACTURER RECEIVED A COPY OF USER FACILITY MEDWATCH REPORT (REPORT NUMBER #: (B)(4)) VIA ITS US IMPORTER. IT WAS REPORTED THAT THE PATIENT WAS IN FOR A PLANNED PCI FOR A TOTAL OCCLUDED RIGHT CORONARY ARTERY WITH SEVERE CALCIFICATION. AN ASAHI MICROCATHETER WAS USED TO ASSIST IN CROSSING THE LESION. IT WAS UNABLE TO CROSS THE LESION AND WHILE ATTEMPTING TO REMOVE THE MICROCATHETER FELT SOME RESISTANCE. UPON REMOVAL OF THE CATHETER, THE TIP OF THE MICROCATHETER WAS NOTICED MISSING. FLUOROSCOPY NOTED THE TIP OF THE MICROCATHETER REMAINED IN THE RIGHT CORONARY ARTERY OVER THE GUIDE WIRE. THE GUIDE WIRE WAS WITHDRAWN TO THE GUIDING CATHETER AND A BALLOON WAS INSERTED TO HELP RETRIEVE THE TIP. THE GUIDING CATHETER AND THE TIP OF THE MICROCATHETER SUSTAINED NO CLINICAL COMPLICATION AS A RESULT AND THE PATIENT WAS DISCHARGED HOME ON THE SAME DATE.

  Patient problems: No Information

  MAUDE report 8194517 ↗
• InjuryNov 1, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE PCI WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE PROXIMAL TO MID LAD. AN ASAHI WIRE WAS ABLE TO ADVANCE THROUGH THE LESION. THE LAD WAS VERY TORTUOUS AND AT THE MID SECTION WAS HEAVILY CALCIFIED. A NON-ASAHI PENETRATION CATHETER WAS USED. THE LESION WAS SO TIGHT THAT IT MADE THE CATHETER KINKED. IT WAS NEEDED TO EXCHANGE OUT THE GUIDE WIRE TO ANOTHER WIRE IN ORDER TO DO ATHERECTOMY, SO THAT THE CATHETER WAS CHANGED TO THE SUBJECT CATHETER. THE CATHETER WAS ADVANCED THROUGH THE LESION BY PUSHING. IT WENT ACROSS THE LESION. THEN THE GUIDE WIRE WAS SWITCHED OUT FOR AN ATHERECTOMY WIRE. WHEN THE CATHETER WAS PULLED BACK THROUGH THE HEAVILY CALCIFIED LESION, IT WAS NOTICED THAT THE TIP SEPARATED FROM THE SHAFT OF THE CATHETER. UNFORTUNATELY THE ATHERECTOMY DEVICE WAS NEEDED AND WHEN THE GUIDE WIRE WAS PULLED BACK SOME, THE SEPARATED TIP CAME OFF THE WIRE AND FLOATED DOWN INTO A SEPTAL PERFORATOR. PROCEDURE TOOK OVER 4.5 HOURS AT THAT TIME, PLUS THE PATIENT WAS (B)(6), THE PHYSICIAN DECIDED TO MAKE NO ATTEMPT TO GET THE SEPARATED TIP OUT OF THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Vessel Or Plaque, Device Embedded In

  MAUDE report 6992595 ↗